MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIGUN RATCHET; DISPENSER, CEMENT

Catalog Number 4195

Device Problems Defective Component (2292); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is ongoing.A supplemental will be sent once the investigation is performed.

Event Description

It has been reported that there was a jamming of the optigun ratchet.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, d5, d10, g1-2, g4, h2, h3, h6, h8, h10.Complaint sample was evaluated and the reported event was confirmed.The product analysis shows that the handle doesn¿t come in the correct position.It must be pushed to come in the correct position.The review of the device manufacturing quality record indicates that (b)(4) products designation optigun ratchet, reference 4195, lot number 0209860012 were manufactured on 03 february 2015.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.No similar complaint has been recorded for optigun ratchet, reference 4195, batch 0209860012 within one year.The probable root cause is the wear of the product and the fouling inside the optigun.An investigation has been performed, consisting of a documentary review and a product analysis.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.The product analysis shows that the handle doesn¿t come in the correct position.The probable cause is the wear of the optigun.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported that the trigger of the optigun ratchet malfunctioned.No adverse events have been reported as a result of the malfunction.

• Brand Name: OPTIGUN RATCHET
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8428079
• MDR Text Key: 139097524
• Report Number: 3006946279-2019-00175
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07350023771603
• UDI-Public: (01)07350023771603
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4195
• Device Lot Number: 209860012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1